Calculating sample size for a

case-control study
Statistical Power
 Statistical power is the probability of
finding an effect if it’s real.
 Factors Affecting Power
1. Size of the effect
2. Standard deviation of the characteristic
3. Bigger sample size
4. Significance level desired
Sample size calculations
 Based on these elements, you can write
a formal mathematical equation that
relates power, sample size, effect size,
standard deviation, and significance
level.
Calculating sample size for a case-
control study: binary exposure
 Use difference in proportions formula…
 formula for difference in
proportions Represents the
desired power
r=ratio of (typically .84 for
Sample size in the
controls to cases 80% power).
case group

r  1 ( p )(1  p )( Z   Z/2 )
2

n( )
r (p1  p2 ) 2

Represents the
A measure of desired level of
Effect Size
variability (similar to statistical
(the difference
standard deviation) significance
in
(typically 1.96).
Example
 How many cases and controls do you
need assuming…
 80% power
 You want to detect an odds ratio of 2.0 or
greater
 An equal number of cases and controls
(r=1)
 The proportion exposed in the control
group is 20%
 Example, continued…
r  1 ( p )(1  p )( Z   Z/2 )
2

n( )
r (p1  p2 ) 2
 For 80% power, Z=.84
 For 0.05 significance level, Z=1.96
 r=1 (equal number of cases and controls)
 The proportion exposed in the control group is 20%
 To get proportion of cases exposed:
ORpcontrols exp 2.0(.20) .40
pcase exp  pcase exp    .33
pcontrols exp (OR  1)  1 (.20)(2.0  1)  1 1.20
 Average proportion exposed = (.33+.20)/2=.265
 Example, continued…
r  1 ( p )(1  p )( Z   Z/2 )
2

n( )
r (p1  p2 ) 2

(.265)(1  .265)(.84  1.96) 2

n2  181
(.33  .20) 2

 Therefore, n=362 (181 cases, 181 controls)

Calculating sample size for a case-
control study: continuous exposure
 Use difference in means formula…
 formula for difference in
means
Represents the
r=ratio of desired power
Sample size in the (typically .84 for
controls to cases
case group 80% power).

r  1  ( Z   Z/2 )
2 2

n( ) 2
r (difference)
Represents the
Standard deviation Effect Size desired level of
of the outcome (the difference statistical
variable in means) significance
(typically 1.96).
Example
 How many cases and controls do you need
assuming…
 80% power
 The standard deviation of the characteristic you
are comparing is 10.0
 You want to detect a difference in your
characteristic of 5.0 (one half standard deviation)
 An equal number of cases and controls (r=1)
 Example, continued…
r  1  ( Z   Z/2 )
2 2

n( ) 2
r (difference)
 For 80% power, Z=.84
 For 0.05 significance level, Z=1.96
 r=1 (equal number of cases and controls)
 =10.0
 Difference = 5.0
Example, continued…
r  1  ( Z   Z/2 )
2 2

n( ) 2
r (difference)
2
10 (7.84)
n  (2) 2
 (2)2 (7.84)  63
2

(5)

 Therefore, n=126 (63 cases, 63 controls)